BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15045302 · Received July 18, 2022

    Report

    Report Number
    1644487-2022-00864
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 23, 2022
    Report Date
    September 7, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN IMPLANTING THE M1000 GENERATOR DURING REPLACEMENT, THERE WAS AN ERROR CODE 14. THEY RAN DIAGNOSTICS TWICE. SHE STATED THAT THIS WAS A NEW GENERATOR AND THE BATTERY LIFE WAS FULL. THERE WAS NO ELECTRICAL SURGICAL TOOLS USED ONCE THE NEW M1000 WAS IN THE FIELD. A SECOND GENERATOR M1000 WAS USED INSTEAD AND NO ERROR CODES WERE SEEN. THE SUSPECT PRODUCT HAS BEEN RECEIVED INTO PRODUCT ANALYSIS AND IS AWAITING COMPLETION OF ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS (PA) WAS COMPLETED FOR THE GENERATOR. INITIAL DATA DOWNLOAD SHOWS A BOR RESET OCCURRED ON (B)(6) 2022, WHICH WAS THE DAY OF SURGERY WHEN THIS DEVICE WAS ALMOST IMPLANTED. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE IMPLANT WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REBOOT. OTHER VISUAL OBSERVATIONS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. AN INTERROGATION, SYSTEM DIAGNOSTIC TEST, A WANDCOMM DIAG, AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. OTHER THAN THE NOTED EVENT (REBOOT), THERE WERE NO ADDITIONAL PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. REVIEW OF INTERNAL DATA REVEALED SEVERAL INCIDENCES OF HIGH IMPEDANCE. SINCE THIS DEVICE WAS NEVER IMPLANTED AND THE HIGH IMPEDANCE IS LIKELY DUE TO THE GENERATOR NOT BEING CONNECTED TO THE LEAD OR DURING SURGERY, THIS WILL NOT BE CAPTURED. ALTHOUGH THE ORSS PREVIOUSLY VERIFIED THAT THE DEVICE WAS NOT EXPOSED TO ELECTROCAUTERY, GIVEN THE REBOOT 2 CODE AND BURN MARKS ON THE OUTSIDE OF THE GENERATOR, THE CAUSE OF PREMATURE BATTERY DEPLETION IS LIKELY EXPOSE TO ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924207 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 575 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown